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FDA approves Eagle Pharmaceuticals' Ryanodex for treatment of Malignant Hyperthermia


Wednesday, 23 Jul 2014 07:00am EDT 

Eagle Pharmaceuticals Inc:Says that the U. S. Food and Drug Administration (FDA) has approved Ryanodex(reg) (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures.MH is an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals.FDA had designated Ryanodex as an Orphan Drug in Aug. 2013.Eagle has been informed by the FDA that it will learn over the next four to six weeks if it has been granted the seven year Orphan Drug market exclusivity.Eagle is the exclusive licensee of four U.S. patents for Ryanodex. Approval of Ryanodex represents two major milestones: in addition to adding to the Company's portfolio of approved compounds, Ryanodex represents the first product to be solely marketed by the Company.